JL. A lot of this goes back to 1994 when DSHEA was passed. Here is a brief Q&A section from the FDA about the impact of DSHEA on what we are talking about:
Who validates claims and what kinds of claims can be made on dietary supplement labels?
FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission.By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product. Different requirements generally apply to each type of claim, and are described in more detail.
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Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a structure/function claim on a dietary supplement label. In general, these claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by FDA. For this reason, the law says that if a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated this claim. The disclaimer must also state that this product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim.
How are advertisements for dietary supplements regulated?
The Federal Trade Commission (FTC) regulates advertising, including infomercials, for dietary supplements and most other products sold to consumers. FDA works closely with FTC in this area, but FTC's work is directed by different laws. For more information on FTC, go to the FTC web site disclaimer icon. Advertising and promotional material received in the mail are also regulated under different laws and are subject to regulation by the U.S. Postal Inspection Service.
I worked as a pharmaceutical chemist after getting out of school so long ago that it seems as though it must have been in pre-Cambrian times. The last 22 years of my working life I have been involved in the supplement industry so I am more familiar with this stuff.
On a more philosophical note, with my knowledge of the function and structure claims permitted by FDA for supplements, I was unbelievable shocked (and not to mention decimated as an Amarin investor) at ADCOM and SPA recession. Totally unbelievable that Amarin could not use Anchor data on label after clinical study completed and agreement to have Reduce-It substantially enrolled. It made and makes no sense. I know I missed my chance to sell on the Marine approval news (ops had risen into the approval) but there is no way any thinking person could have argued that selling just before ADCOM made any sense -- it was the right thing to do obviously seen after the fact - but it just made no sense.
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